# K232493: Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Huchuang Union Technology Co., Ltd.
- Decided: May 7, 2024 after 264 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K040717 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173264: EmbryoScope+, Vitrolife A/S (2018) Summary page 5.

## Indications for use
The Embryo Real-time Incubator (TLS301) is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Embryo Real-time Incubator (TLS301) has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours. The Embryo Real-time Culture Dish (MC 2004) is intended for preparing, storing and transferring human embryos. It is intended to be used only with the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software are optional software accessories for the Embryo Real-time Incubator (TLS301). The Embryo Realtime 2S Software is intended to store, archive and transfer data. In addition, the Embryo Realtime 25 Software includes functions for managing models and performing calculations based on image data and embryo development parameters. Embryo Realtime 3E Software is intended for viewing and recording embryo development events from images captured using the Embryo Real-time Incubator (TLS301). Embryo Realtime 3E Software includes a user annotation function for capturing information on embryo development parameters and a user-defined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection. Embryo Realtime 2S Software and Embryo Realtime 3E Software do not control any hardware components in the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software are provided in different software package and must be used together.

Source page: https://510kreport.com/device/K232493
Methodology: https://510kreport.com/methodology